Field of the Disclosure
The present disclosure relates in general to therapeutic formulations, and more particularly, to a poloxamer-based composition having itraconazole. This composition may be employed in the treatment of fungal and yeast infections.
Background Information
Fungi may cause a wide variety of diseases in humans. While some fungi may cause infections limited to the outermost layers of the skin and hair (superficial mycoses), other fungi may cause cutaneous mycoses by penetrating the keratinized layers of the skin, hair, and nails, and triggering pathologic changes in the host. Subcutaneous mycoses may cause infections in the dermis, subcutaneous tissues, muscle and fascia and are often chronic. Systemic mycoses may originate primarily in the lung and may cause secondary infections in other organ systems in the body.
Conventional treatments for fungal and yeast infections may include topical and oral drugs. Orally administered drugs may be generally more effective than topically applied ones, besides the oral route may generally be the most convenient and carries the lowest cost, however, some drugs may cause gastrointestinal irritation, and then there is a need for rapid delivery of drug than intended. Otherwise, by delivering drugs almost directly to the site of action, the risk of systemic side effects may be reduced; however, skin irritation may result in some topical ingredients.
Generally, the conventional treatment for fungal and yeast infections may include antifungals as active pharmaceutical ingredients (APIs). Topical and oral antifungal used in different kinds of human organs may be effective for treating fungal and yeast infections in human, but most antifungal drugs may cause different kinds of side effects. However, these side effects may be reduced by the use of specific base compositions that may act in a synergistic effect with APIs and improving the dispersibility of APIs. Additionally, despite progress in the medical field, there are still difficulties (slow healing, not efficient dispersibility of APIs) on the fungus treatment for nasal and lung fungal infections, these difficulties mainly affect people living in certain geographic areas, and those with immune deficiency.
For the aforementioned reasons, there is a need for an improved treatment for yeast and fungal infections which may include excipients that may allow the production of an effective composition, thus providing more residence time and exhibiting less side effects.
The following reference is related to the background of the present invention: National Committee for Clinical Laboratory Standards (1997). Reference method for broth dilution antifungal susceptibility testing of yeasts: approved standard. NCCLS document M27-A. National Committee for Clinical Laboratory Standards, Wayne, Pa.
The following reference is related to the background of the present invention: Promega (2013). CellTiter 96® Non-Radioactive Cell Proliferation Assay Technical Bulletin. Available at: http://www.pronnega.conn/resources/protocols/technical-bulletins/0/celltiter-96-non-radioactive-cell-proliferation-assay-protocol (Accessed: 15 May 2014).
The following reference is related to the background of the present invention: Ramage G., Walle K. V., Wickes B. L. López-Ribot J. L. (2001). Standardized Method for In Vitro Antifungal Susceptibility Testing of Candida albicans Biofilms. Antimicrobial Agents and Chemotherapy 45(9): 2475-2479.